Evaluation of pessary placement on the anatomy of the pelvic organs in patients with pelvic organ prolapse using imaging techniques

Recruiting

Conditions: Prolapse - pelvic floor dysfunction
10046828

Registration Number: NL-OMON52584

Lead Sponsor: niversiteit Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 105

Inclusion Criteria

General:
Signed informed consent

Patients:
Symptomatic pelvic organ prolapse
Pelvic organ prolapse quantification stage 2 or higher
Patient underwent a pessary fitting trial by a gynecologist

Exclusion Criteria

General:
Inability to stand for 20 minutes without assistance
Not eligible for MRI, in response to the MRI safety checklist

Controls:
Symptoms related to POP or incontinence (in history)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In general, the main study endpoints are parameters about the position and<br /><br>shape of the pelvic organs that are associated with successful pessary fitting.<br /><br>Both absolute parameter values and changes in these parameters between the<br /><br>scans with and without pessary will be evaluated. For each study specific<br /><br>parameters will be described.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study endpoints are:<br /><br>- Parameters which are associated with (a change of) the position and shape of<br /><br>the pelvic organs due to insertion of a pessary in successful pessary fitting,<br /><br>measured using several imaging techniques.<br /><br>- Position and orientation of the pessary in successful pessary fitting.<br /><br>- Influence of the moment of the day on the position of the pelvic organs.<br /><br>- Correlation between the position and orientation of the pessary and<br /><br>anatomical aspects of the levator ani muscle.<br /><br>- Differences in parameters between patients with successful (i.e. continuation<br /><br>of pessary use for >= 3 months) and unsuccessful pessary fitting.<br /><br><br /><br>These parameters will be investigated in the different studies described in<br /><br>this framework. </p><br>